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Discoid lupus drug trial halted midway

NCT ID NCT05591222

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called daxdilimab in 72 adults with moderate-to-severe discoid lupus erythematosus, a skin condition that causes scarring and hair loss. The goal was to see if the drug could reduce disease activity compared to a placebo. However, the trial was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

72 people

The number who actually took part.

Started

Dec 2022

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Willing and able to understand and provide written informed consent. * Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. * A diagnosis of DLE for ≥ 6 months prior to screening supported by a history of: 1. A biopsy or 2. a clinical feature score of ≥ 7 on the DLE Classification Criteria (DLECC) scale. * Currently active discoid lupus with all the following: 1. Digital photography adjudicated with central reading to confirm a currently active discoid disease lesion. 2. CLASI-A score ≥ 8 related to discoid lesions at Baseline. * Treatment refractory DLE defined as active disease despite current or historical treatment with a systemic treatment. * Females are eligible to participate if they are not pregnant or breastfeeding, and meet the contraceptive/barrier requirement(s). * Males are eligible to participate if they agree to the contraceptive/barrier requirement(s). * Vaccination status should be up to date per local standards. Key Exclusion Criteria: * Participation in another clinical study with an investigational drug within 4 weeks prior to Randomization or within 5 published half-lives, whichever is longer. * Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product (IP) or interpretation of participant safety or trial results. * Weight \> 160 kg (352 pounds) at Screening. * History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous monoclonal antibody (mAb) or human immunoglobin (Ig) therapy. * Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the informed consent form (ICF) through 6 months after receiving the last dose of IP. * Splenectomy. * Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to screening through randomization. * History of clinically significant cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to Randomization; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities. * History of cancer within the past 5 years, except as follows: * Cutaneous basal cell or squamous cell carcinoma treated with curative therapy. * Any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection. * Known history of a primary immunodeficiency or an underlying condition, such as known human immunodeficiency virus (HIV) infection, or a positive result for HIV infection per central laboratory. * Participants with positive hepatitis B serologic test results. * All participants will undergo testing for hepatitis C antibody (HCVAb) during Screening. * Participants who are HCVAb positive will be reflex tested for hepatitis C virus (HCV) RNA and if HCV RNA is positive, the participant is not eligible for the study. * Active tuberculosis (TB), or a positive interferon-gamma release assay (IGRA) test at screening, unless documented history of appropriate treatment for active or latent TB. Participants with an indeterminate IGRA test result can repeat the test, but if the repeat test is also indeterminate, they will be excluded. * Any severe herpes virus family infection (including Epstein-Barr virus, cytomegalovirus (CMV)) at any time prior to Randomization, including, but not limited to, disseminated herpes, herpes encephalitis, recent recurrent herpes zoster (defined as 2 episodes within the last 2 years), or ophthalmic herpes. * Any herpes zoster, CMV, or Epstein-Barr virus infection that was not completely resolved 12 weeks prior to Randomization. * Opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within 2 years prior to Randomization. * Any acute illness or evidence of clinically significant active infection on Day 1. * Participants who have COVID-19 or other significant infection, or in the judgment of the Investigator, may be at a high risk of COVID-19 or its complications should not be randomized. * Systemic lupus erythematosus defined by fulfilling 2020 American College of Rheumatology/European Alliance of Associations for Rheumatology criteria for systemic lupus erythematosus (SLE). * Current diagnosis of a systemic connective tissue disease. * Current inflammatory skin disease other than DLE, that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments and confound the disease activity assessments. * Exposure to an experimental drug either 30 days, 5 half-lives of the agent, or twice the duration of the biological effect of the agent, whichever is longer, prior to Randomization and through the final trial visit. * Receipt of a live-attenuated vaccine within 4 weeks prior to Randomization.

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Conditions

The condition(s) this trial relates to.

connective tissue disorder cutaneous lupus erythematosus discoid lupus erythematosus immune system disorder skin disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Discoid lupus erythematosus

Contacts and locations

Locations

  • 401 General Military Hospital of Athens

    Athens, 11525, Greece

  • Alberta DermaSurgery Centre

    Edmonton, Alberta, T6G 1C3, Canada

  • Ambulatory for specialized medical care - individual practice for specialized medical care - skin and venereal diseases

    Sofia, 1407, Bulgaria

  • Andreas Syggros Hospital

    Athens, 16121, Greece

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72117, United States

  • Autoimmune Skin Diseases Unit, Dept. of Dermatology

    Philadelphia, Pennsylvania, 19104, United States

  • BAG Dr. Freitag und Knöll

    Falkensee, Brandenburg, 14612, Germany

  • Bispebjerg Hospital, Dermato-Venerologisk Afdeling Og Videncenter for Sårheling, D/S.

    Copenhagen NV, 2400, Denmark

  • Brunswick Dermatology Center

    Fredericton, New Brunswick, E3B 1G9, Canada

  • CHU Poitiers - Hôpital la Milétrie

    Poitiers, 86021, France

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, 76031, France

  • CIPREC

    Ciudad Autonoma Buenos Aires, C1061AAS, Argentina

  • Center for Clinical Studies (Cypress)

    Houston, Texas, 77065, United States

  • Centralny Szpital Kliniczny MSWiA

    Warsaw, 02-807, Poland

  • Centro Multidisciplinar de Estudos Clinicos

    São Bernardo do Campo, São Paulo, 09715, Brazil

  • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.

    Malbork, 82-200, Poland

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Clinical Research Group Sp. z o.o.

    Warsaw, 01-142, Poland

  • Clinical Science Institute

    Santa Monica, California, 90404, United States

  • Complexo Hospitalar de Niterói

    Niterói, Rio Do Janeiro, 24020-076, Brazil

  • DCC "Alexandrovska" EOOD

    Sofia, 1431, Bulgaria

  • DCC 'Sveti Georgi' EOOD

    Haskovo, 6300, Bulgaria

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • DermEffects

    London, Ontario, N6H 5L5, Canada

  • Detroit Clinical Research Center, PC

    Farmington Hills, Michigan, 48334, United States

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 602 00, Czechia

  • Forest Hills Dermatology

    Forest Hills, New York, 11375, United States

  • Fundacion Scherbovsky

    Mendoza, Mendoza Province, CP5500, Argentina

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto, CIP - Centro Integrado de Pesquisa

    Sao Jose Rio, Preto Sao Paulo, 15090-000, Brazil

  • Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde da Universidade de Caxias do Sul

    Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil

  • General Hospital Papageorgiou

    Thessaloniki, 56429, Greece

  • General Hospital of Athens "Evangelismos"

    Athens, 10676, Greece

  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

    Fortaleza, Ceará, 60430-275, Brazil

  • Hopital Edouard Herriot - CHU Lyon

    Lyon, 69003, France

  • Hospital Christovão da Gama - Centro de Estudos

    Santo André, São Paulo, 09030-010, Brazil

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

  • Hospital Universitário Evangélico Mackenzie

    Água Verde, Paraná, 80240-220, Brazil

  • IMC - Instituto de Moléstias Cardiovasculares Tatuí

    Tatuí, São Paulo, 18270-170, Brazil

  • IPITEC Instituto de Pesquisa Inovação Tecnológica

    São Paulo, 01223-001, Brazil

  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

    Rio de Janeiro, Rio Do Janeiro, 20241-180, Brazil

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

  • K. Papp Clinical Research

    Waterloo, Ontario, N2J 1C4, Canada

  • Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina

    Rzeszów, 35-055, Poland

  • Klinikum Oldenburg AöR

    Oldenburg, Lower Saxony, 26133, Germany

  • LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki

    Szczecin, 70-332, Poland

  • LMK Serviços Médicos S/S

    Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506, United States

  • Medical Center Eurohealth EOOD

    Sofia, 1606, Bulgaria

  • Miami Dermatology & Laser Research

    Miami, Florida, 33173, United States

  • Michigan Dermatology Institute

    Waterford, Michigan, 48328, United States

  • Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112, United States

  • North York Research, Inc

    Toronto, Ontario, M2N 3A6, Canada

  • OUH

    Odense C, 5000, Denmark

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Paddington Testing Company, Inc.

    Philadelphia, Pennsylvania, 19103, United States

  • Sanatorium Profesora Arenbergera

    Prague, 110 00, Czechia

  • Service de dermatologie, hôpital Archet 2, CHU NICE

    Nice Alpes, Maritimes, 6200, France

  • Sjællands Universitetshospital

    Roskilde, 4000, Denmark

  • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Pawel Brzewski Spolka Cywilna

    Krakow, 30-002, Poland

  • The Center for Dermatology Clinical Research

    Fremont, California, 94538, United States

  • Universidade Estadual de Campinas

    Campinas, São Paulo, 13083-888, Brazil

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, Rhineland-Palatinate, 55131, Germany

  • University General Hospital "Attikon"

    Athens, 12462, Greece

  • University General Hospital of Larissa

    Larissa, 41110, Greece

  • Universitätsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie

    Dresden, Saxony, 01307, Germany

  • Wallace Medical Group

    Beverly Hills, California, 90211, United States

  • Wright State Physicians

    Fairborn, Ohio, 45324, United States

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